HFCWO Vest Plus Mechanical Cough Assist Versus Cough Assist Alone on Respiratory Infections in ALS: a Pilot Trial

June 16, 2026 updated by: Hospital Universitario Virgen Macarena

Effect of High-frequency Chest Wall Oscillation (HFCWO) Via Chest Vest Combined With Mechanical Cough Assist Versus Mechanical Cough Assist Alone on Respiratory Infections and Hospital Admissions in Patients With Amyotrophic Lateral Sclerosis Receiving Non-invasive Ventilation: a Randomised Single-blind Pilot Trial

This pilot randomised single-blind trial evaluated whether adding high-frequency chest wall oscillation (HFCWO) via chest vest (ComfortCough II) to mechanical cough assist improves respiratory outcomes and reduces respiratory infections and hospital admissions compared to mechanical cough assist alone in patients with amyotrophic lateral sclerosis (ALS) receiving non-invasive ventilation.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Patients with amyotrophic lateral sclerosis (ALS) receiving non-invasive ventilation (NIV) at the Multidisciplinary ALS Unit of Hospital Universitario Virgen Macarena (Seville, Spain) were randomised to two parallel groups. The experimental group received high-frequency chest wall oscillation (HFCWO) via chest vest (ComfortCough II/CC20) combined with mechanical cough assist, while the control group received mechanical cough assist alone. The intervention period lasted 3 months, followed by 3 months of follow-up. Primary outcomes included respiratory infections and hospital admissions. Secondary outcomes included respiratory function, quality of life, sleep quality, and secretion clearance capacity. The study was approved by the Ethics Committee of Hospital Universitario Virgen Macarena - Virgen del Rocío (code 2020-01) and sponsored by FISEVI (Fundación Pública Andaluza para la Investigación Biosanitaria de Andalucía).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Andalusia
      • Seville, Andalusia, Spain, 41009
        • Hospital Universitario Virgen Macarena

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Confirmed diagnosis of ALS according to the Revised El Escorial criteria
  2. Under follow-up at the Multidisciplinary ALS Unit of Hospital Universitario Virgen Macarena
  3. Age between 18 and 90 years
  4. Peak cough flow less than 270 L/min or forced vital capacity (FVC) less than 80% of predicted
  5. Ability to travel to the Neurolab centre

exclusion criteria:

  1. Need for invasive mechanical ventilation
  2. Total dependence on non-invasive ventilation (NIV)
  3. Severe bulbar involvement
  4. Cognitive impairment
  5. Comorbidities incompatible with the intervention: pregnancy, rib fractures, known risk of pneumothorax or pneumomediastinum, cerebrospinal fluid fistula, pneumocephalus, or recent barotrauma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: arm label Experimental: HFCWO plus mechanical cough assist
Patients received high-frequency chest wall oscillation via chest vest (ComfortCough II) combined with mechanical cough assist for 3 months followed by 3 months follow-up.
Device: High-frequency chest wall oscillation (HFCWO) vest
Chest wall oscillation vest delivering high-frequency vibrations to mobilise secretions, used in addition to mechanical cough assist device during the 3-month intervention period.
Other Names:
  • ComfortCough II , CC20
Device: Mechanical cough assist
Mechanical insufflation-exsufflation device used alone for airway secretion clearance during the 3-month intervention period.
Other Names:
  • Cough assist device
Active Comparator: Control: Mechanical cough assist alone
Patients received mechanical cough assist alone for 3 months followed by 3 months follow-up.
Device: Mechanical cough assist
Mechanical insufflation-exsufflation device used alone for airway secretion clearance during the 3-month intervention period.
Other Names:
  • Cough assist device

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of respiratory infections
Time Frame: 6 months (3 months intervention plus 3 months follow-up)
Number of respiratory infections requiring antibiotic treatment during the study period
6 months (3 months intervention plus 3 months follow-up)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of hospital admissions
Time Frame: 6 months (3 months intervention plus 3 months follow-up)
Number of hospital admissions due to respiratory causes during the study period
6 months (3 months intervention plus 3 months follow-up)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Forced Vital Capacity (FVC)
Time Frame: 6 months
Change in forced vital capacity percentage from baseline
6 months
Peak Cough Flow (PCF)
Time Frame: 6 months
Change in peak cough flow from baseline
6 months
Gait analysis
Time Frame: 6 months
Change in gait parameters assessed by GAITRite electronic walkway system and correlation with respiratory function (FVC)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Universitario Virgen Macarena

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Concepcion Romero Muñoz, Hospital Universitario Virgen Macarena

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 2, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 18, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Tosedores 1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Amyotrophic Lateral Sclerosis

Clinical Trials on High-frequency chest wall oscillation (HFCWO) vest

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings